Study Evaluating Single Doses of GAP-134

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The purpose of this study is to assess the safety and tolerability of ascending single oral doses of GAP-134 in healthy subjects, to provide the initial pharmacokinetic profile of the oral formulation of GAP-134 in healthy subjects, and to evaluate the effect on the pharmacokinetic profile of a high-fat meal of 450 mg of GAP-134 administered to healthy subjects.

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Ages Eligible for Study:

18 Years to 50 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria

Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive at screening.

WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥1 year (with follicle stimulating hormone [FSH] level ≥38 mIU/mL) and must have a negative pregnancy test result within 24 hours before administration of the study drug or placebo.

Women who are surgically sterile must provide documentation of the procedure by an operative report or by an ultrasound scan report.

Sexually active men must agree to use a medically acceptable form of contraception during the study and continue using it for 12 weeks after study drug or placebo administration.